Device Recall Continuous Ventilator

  • Modèle / numéro de série
    Serial No. 1000 thru 2090; P/N 951001
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to IL and TX.
  • Description du dispositif
    Intellicuff Standalone (PN 951001) || Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation of adults, pediatrics, and neonates.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Hamilton Medical, Inc., 4990 Energy Way, Reno NV 89502-4123
  • Société-mère du fabricant (2017)
  • Source
    USFDA